Daewoong Pharmaceutical Obtains Philippine Approval for New GERD Drug 'Pexuclu'

Daewoong Pharmaceutical Fexuclu. [Photo by Daewoong Pharmaceutical]

[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical announced on the 10th that its 34th domestic new drug, "Pexuclu" (active ingredient: fexuprazan hydrochloride), has obtained product approval from the Philippines FDA (The Philippines Food and Drug Administration).

This approval was granted about eight months after the submission of the New Drug Application (NDA) in February. Generally, it is known to take about three years to receive product approval in the Philippines. Daewoong Pharmaceutical significantly shortened this period based on its expertise in preparing the necessary submission documents for approval.

In line with this, Daewoong Pharmaceutical plans to hold a Pexuclu symposium on the 24th, inviting key opinion leaders including the president of the Philippine Society of Gastroenterology, to share directions and opinions on entering the Philippine market.

Daewoong Pharmaceutical plans to submit NDAs to 10 countries worldwide by the end of this year. So far, the countries where product approval applications have been submitted include eight countries: the Philippines, which has already obtained approval, Brazil, Indonesia, Thailand, Mexico, Chile, Ecuador, and Peru.

Pexuclu is a new drug for gastroesophageal reflux disease officially launched domestically in July this year. It is a P-CAB (potassium-competitive acid blocker) formulation. It improves on the drawbacks of existing PPI (proton pump inhibitor) formulations by binding to the proton pump without requiring activation by stomach acid, thereby inhibiting acid secretion quickly and stably.

The currently secured indications for Pexuclu are two: ▲treatment of erosive gastroesophageal reflux disease (40 mg) and ▲improvement of gastric mucosal lesions in acute and chronic gastritis (10 mg). Notably, Pexuclu is the only P-CAB drug in Korea with an indication for gastritis, and recently, research results on Pexuclu’s gastritis indication were presented at the European Society of Gastroenterology.

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, "It is very encouraging that Pexuclu received approval in the Philippines, one of Daewoong Pharmaceutical’s branch countries, with a significantly shortened approval period, which proves Daewoong Pharmaceutical’s global business capabilities. We will successfully complete the Philippine symposium scheduled for this month to ensure that Pexuclu is successfully established in the Philippines."

This content was produced with the assistance of AI translation services.